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Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy for High-Risk Localized Prostate Cancer — Open-Label Randomized Clinical Study


Phase 3
20 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy for High-Risk Localized Prostate Cancer — Open-Label Randomized Clinical Study


Subjects (N=182) who have high-risk prostate cancer and have undergone primary prostate
cryotherapy will be screened and randomized in a 1:1 ratio to receive either adjuvant ADT
(Adj-ADT) or No-ADT until disease progression. Screening and randomization will be done
within four weeks after cryoablation. Only those who are assigned to Adj-ADT will receive
ADT for a total of 12 months. PSA will be checked every 3 months in the first year after
Cryo and every 6 months thereafter. Long-term follow-up parameters include serum PSA and
protocol-mandated biopsies (at 36 months after Cryo, irrespective of PSA levels if
recurrence has not been documented). For-cause biopsy will also be done if post-Cryo PSA
elevation reaches the Phoenix criteria (Nadir + 2 ng/ml) or when the treating physician
thinks it necessary to document tumor recurrence.


Inclusion Criteria:



1. Age>20 years

2. Histopathology proven prostate adenocarcinoma

3. Non-metastatic localized disease

4. Prostate cancer is deemed high-risk for recurrence(PSA>20 ng/ml, Gleason score>=8, or
clinical staging>=T2c)

5. Subjects have undergone prostate cryoablation as the definitive treatment prior to
enrolling the study

6. Subjects who have not been treated with any definitive treatments for prostate
cancer, including radical prostatectomy or definitive radiotherapy. However, those
who have undergone focal prostate cryoablation and have cancer recurrence are still
eligible.

7. Subjects may or may not have received neoadjuvant androgen-deprivation therapy (ADT)
in the forms of either castration (medical) and/or antiandrogens. Surgical castration
(orchiectomy) is not allowed.

8. Subjects are willing to sign the informed consent and agree to comply with the study
procedures

Exclusion Criteria:

1. Those who have been treated with > 8 weeks (collectively if not continuously) of
neoadjuvant ADT prior to screening.

2. Subjects who have other cancer that is deemed not cured or are known less than 5
years except for basal cell carcinoma of the skin

3. Other conditions the investigators think may affect subject compliance or safety

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

A composite trifecta endpoint of treatment failure at 3 years after cryoablation

Outcome Description:

A composite trifecta endpoint of treatment failure at 3 years after cryoablation defined by either of the three, biochemical (PSA) recurrence (by the Phoenix criteria) or biopsy-proven recurrence or initiation of hormone therapy for disease recurrence whichever comes first.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Yeong-Shiau Pu, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital

Authority:

Taiwan: Department of Health

Study ID:

201103057MB

NCT ID:

NCT01398657

Start Date:

July 2011

Completion Date:

June 2016

Related Keywords:

  • Prostate Cancer
  • localized
  • High risk
  • Prostate Cancer
  • Randomized
  • Cryotherapy
  • Cryoablation
  • Adjuvant
  • Androgen Deprivation Therapy
  • Hormone therapy
  • ADT
  • Prostatic Neoplasms

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